Back to resultsDCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer
Primary Purpose
Ovarian Cancer Recurrent
Status
Completed
Phase
Phase 2
Locations
Czechia
Study Type
Interventional
Intervention
DCVAC/OvCa
Standard of Care Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer Recurrent focused on measuring Immunotherapy, Platinum-sensitive, Biologic, Vaccine, Ovarian cancer, Fallopian Tube cancer, Primary peritoneal cancer, dendritic cells, chemotherapy, leukapheresis, FIGO III, FIGO IV
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically confirmed FIGO stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous,endometrioid, or mucinous) who had complete remission after first-line platinum-based chemotherapy
- Radiologically confirmed relapse after >6 months of remission ( platinum-sensitive cancer)
- Laboratory parameters per protocol
Exclusion Criteria:
- FIGO I, II epithelial ovarian cancer
- FIGO III, IV clear cells epithelial ovarian cancer
- Non-epithelial ovarian cancer
- Borderline tumors ( tumors of low malignant potential)
- Prior or current systemic anti-cancer therapy for ovarian cancer (chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitory therapy, vascular endothelial growth factor or hormonal therapy) except first-line Pt based chemotherapy ( with or without bevacizumab)
- fertile women of child-bearing potential not willing to use a highly effective method of contraception or a combination of methods
- Pregnant of lactating women
- Pre-defined co-morbidities
- Known hypersensitivity to any constituent of DCVAC/OVCa or the selected chemotherapy compounds
Sites / Locations
- University Hospital Brno
- Masaryk Memorial Cancer Institute
- Hospital Novy Jicin
- University Hospital in Ostrava
- University Hospital Plzen
- University Hospital Kralovsko Vinohrady
- General University Hospital in Prague
- Hospital Bulovka
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Standard of care chemotherapy + DCVAC/Ov
Arm Description
Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa
Outcomes
Primary Outcome Measures
Progression Free Survival by modifications to the RECIST 1.1
PFS as defined as the time from the first dose of Standard-of-Care (SoC) therapy administerd until tumor progression or death from any cause
Secondary Outcome Measures
Overall survival
Defined as the time from first dose of SoC therapy administered until death due to any cause assessed until study completion
Biological progression-free interval
Defined by increasing CA-125 levels per Gynecologic Cancer Intergroup (GCIG) criteria
Objective Response rate
CR and PR measured by the modifed RECIST 1.1 criteria
Immunologic Response
Detection of entire anti-tumor immune response int he serum
Incidence of Treatment-emergent adverse events [safety and tolerability]
Safety profile as determined by the nature, incidence, duration, severity and outcome of adverse events (AEs) including serious AEs (SAEs) as assessed by CTCAE v. 4.0
CA-125 response
Defined by GCIG criteria
Time to either tumor or biologic Response
Response according to RECIST or CA-125 measurements as increased to >2 times ULN
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03657966
Brief Title
DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer
Official Title
An Open-label, Single-group, Multi-center, Phase II Clinical Trial Evaluating the Effect of Maintenance DCVAC/OvCa After Standard-of-care Therapy in Women With First Relapse of Platinum-sensitive Epithelial Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 23, 2017 (Actual)
Primary Completion Date
November 11, 2020 (Actual)
Study Completion Date
February 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOTIO a.s.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial ovarian carcinoma who experienced relapse more than 6 months after complete remission of first line platinum-based chemotherapy (platinum sensitive ovarian cancer)
Detailed Description
All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure. All eligible/enrolled patients will receive standard-of-care therapy with carboplatin/gemcitabine or carboplatin/paclitaxel starting 2 to 7 days after leukapheresis.
After 6 cycles of chemotherapy, patients will start maintenance treatment with DCVAC/OvCa.
Treatment will continue irrespective of tumor progression until completion, refusal, intolerance of treatment or death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer Recurrent
Keywords
Immunotherapy, Platinum-sensitive, Biologic, Vaccine, Ovarian cancer, Fallopian Tube cancer, Primary peritoneal cancer, dendritic cells, chemotherapy, leukapheresis, FIGO III, FIGO IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
open-label DCVAC/OvCa after treatment with carboplatin in combination with either gemcitabine or paclitaxel
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care chemotherapy + DCVAC/Ov
Arm Type
Experimental
Arm Description
Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa
Intervention Type
Biological
Intervention Name(s)
DCVAC/OvCa
Intervention Description
activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy
Intervention Type
Drug
Intervention Name(s)
Standard of Care Chemotherapy
Other Intervention Name(s)
carboplatin with gemcitabine, carboplatin with paclitaxel
Intervention Description
either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa
Primary Outcome Measure Information:
Title
Progression Free Survival by modifications to the RECIST 1.1
Description
PFS as defined as the time from the first dose of Standard-of-Care (SoC) therapy administerd until tumor progression or death from any cause
Time Frame
Assessed from enrollment up to 104 weeks
Secondary Outcome Measure Information:
Title
Overall survival
Description
Defined as the time from first dose of SoC therapy administered until death due to any cause assessed until study completion
Time Frame
Assessed from enrolment through study completion approximately 5 years
Title
Biological progression-free interval
Description
Defined by increasing CA-125 levels per Gynecologic Cancer Intergroup (GCIG) criteria
Time Frame
CA-125 assessed every 6 weeks up to 104 weeks
Title
Objective Response rate
Description
CR and PR measured by the modifed RECIST 1.1 criteria
Time Frame
Response is assessed every 8 weeks up to 104 weeks
Title
Immunologic Response
Description
Detection of entire anti-tumor immune response int he serum
Time Frame
Blood samples collected 5 times throughout the study from enrolment up to 104 weeks
Title
Incidence of Treatment-emergent adverse events [safety and tolerability]
Description
Safety profile as determined by the nature, incidence, duration, severity and outcome of adverse events (AEs) including serious AEs (SAEs) as assessed by CTCAE v. 4.0
Time Frame
Screening through 30 days after completion of treatment
Title
CA-125 response
Description
Defined by GCIG criteria
Time Frame
CA-125 assessed every 6 weeks up to 104 weeks
Title
Time to either tumor or biologic Response
Description
Response according to RECIST or CA-125 measurements as increased to >2 times ULN
Time Frame
From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks.
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with histologically confirmed FIGO stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous,endometrioid, or mucinous) who had complete remission after first-line platinum-based chemotherapy
Radiologically confirmed relapse after >6 months of remission ( platinum-sensitive cancer)
Laboratory parameters per protocol
Exclusion Criteria:
FIGO I, II epithelial ovarian cancer
FIGO III, IV clear cells epithelial ovarian cancer
Non-epithelial ovarian cancer
Borderline tumors ( tumors of low malignant potential)
Prior or current systemic anti-cancer therapy for ovarian cancer (chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitory therapy, vascular endothelial growth factor or hormonal therapy) except first-line Pt based chemotherapy ( with or without bevacizumab)
fertile women of child-bearing potential not willing to use a highly effective method of contraception or a combination of methods
Pregnant of lactating women
Pre-defined co-morbidities
Known hypersensitivity to any constituent of DCVAC/OVCa or the selected chemotherapy compounds
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald Fricke, MD, PhD
Organizational Affiliation
SOTIO a.s.
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Masaryk Memorial Cancer Institute
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Hospital Novy Jicin
City
Nový Jičín
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
University Hospital in Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
University Hospital Plzen
City
Plzen
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
University Hospital Kralovsko Vinohrady
City
Prague
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
General University Hospital in Prague
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Hospital Bulovka
City
Prague
ZIP/Postal Code
180 81
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer
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